Phase 3
N=39
PK of TAF and TDF for PrEP in Pregnant and Postpartum Women
Hiv
Bottom Line
View on ClinicalTrials.gov: NCT04937881 ↗Enrolled (actual)
39
Serious AEs
35.9%
Results posted
Sep 2024
Primary outcome: Primary: Tenofovir Diphosphate (TFV-DP) Levels in Plasma and Intracellular Levels in Pregnant Women on Daily PrEP — 580; 71 TFV-DP PBMC (fmol/10^6cells)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tenofovir alafenamide (Drug); Tenofovir Disoproxil Fumarate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, Los Angeles
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tenofovir Diphosphate (TFV-DP) Levels in Plasma and Intracellular Levels in Pregnant Women on Daily PrEP |
580; 71 | — |
| PRIMARY Tenofovir Diphosphate (TFV-DP) Levels in Plasma and Intracellular Levels in Postpartum Women on Daily PrEP |
666; 73 | — |
| SECONDARY Tenofovir Diphosphate (TFV-DP) Concentrations in Plasma and Intracellular Levels Comparing Pregnancy Against Postpartum Women |
611.3; 410.0; 940.5; 518.3 | — |
Summary
This study will establish benchmarks of TFV-DP concentrations as measures of adherence following daily dosing with Tenofovir Alafenamide (TAF) compared with Tenofovir Disoproxil Fumarate (TDF) during pregnancy and postpartum. Study Investigators will recruit from an ongoing observational cohort study in Cape Town, South Africa, PrEP-PP (recruitment ongoing through July, 2021; NIMH R01MH116771; PI Coates & Myer). Findings form this PK sub-study will be used to inform future PrEP in pregnancy and postpartum studies and develop benchmarks of the relative PK between TDF and TAF.
Eligibility Criteria
Inclusion Criteria
- >18 years old
- confirmed HIV-negative (confirmed with a 4th generation antigen HIV test) at time of study entry
- intend on giving birth in the MOU facility
- confirmed to be 14-24 weeks pregnant
- without psychiatric or medical contraindications to PrEP
- estimated creatinine clearance (CrCI) >60mL/min
- resides close to clinic (<10km)
- has a smart phone that can take video footage (with data bundle from study)
- agrees to provide video phone footage of taking a pill a day for 8 weeks during pregnancy and again for 8 weeks in postpartum period
Exclusion Criteria
Individuals not meeting the above criteria or meeting any of the following criteria will be excluded:
- Concurrent enrolment in another HIV-1 vaccine or prevention trial
- History of renal disease
- Current clinical diagnosis of hypertension
- Exhibiting psychotic symptoms
- Currently or history of taking an anti-psychotic medication
- Positive Hepatitis B surface antigen (HBsAg) test on screening
- History of bone fracture not related to trauma
- Any other medical, psychiatric or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study
- Any maternal or fetal complication, obstetric or medical, detected during routine care or study procedures that requires referral of pregnant or postpartum women/infants to secondary or tertiary obstetric or medical care.
Data sourced from ClinicalTrials.gov (NCT04937881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.